Federal Register / Vol. 47, No. 102 / Wednesday, May 26, 1982 / Notices 
23111 
correspondent questioned whether 
“pharmacologically active molecules” 
such as certain hormones should be 
treated as toxins. Pointing to Section 1- 
B, second paragraph, which cites: “a 
toxin or a pharmacologically active 
agent," the working group agreed that 
the intent of the Guidelines is to cover 
these types of molecules and 
recommended that the language dealing 
with toxins in the Guidelines be 
amended to reflect that intent. 
The working group discussed the issue 
of which document should be utilized to 
determine the pathogenic classification 
of an organism. The original 1976 
Guidelines used the publication 
Classification of Etiologic Agents on the 
Basis of Hazard, 4th Edition, July 1974; 
U.S. Depatment of Health, Education 
and Welfare, Public Health Service, 
Center for Disease Control, as the 
reference source for classification of 
microorganisms for the purposes of the 
Guidelines. All subsequent revisions of 
the Guidelines have also used this 
document. At the present time, the 
Centers for Disease Control (CDCJ and 
the NIH are engaged in an effort to 
revise the Classification of Etiologic 
Agents on the Basis of Hazard. The 
working group felt, however, that this 
revised version might not serve the 
purposes of the Guidelines as well as 
the original 1974 version. Nonetheless, 
the working group noted that additional 
pathogens should be added to the 
classification in the Guidelines and that 
the classification should be updated 
regularly. It was also noted that some 
organisms might better be treated in a 
manner specific for the purposes of the 
Guidelines. The working group 
recommended, therefore, that the RAC 
and NIH adopt for the Guidelines a 
revised version of the 1974 CDC 
classification, and that the RAC should 
assume responsibility for regularly 
updating the listing. The working group 
recommended that (a) the following 
bacteria be added to the list of Class 2 
bacterial agents: 
Aeromonas Hydrophila 
Campylabacter fetus 
Campylobacter jejuni 
Edwardsiella tarda 
Yersinia enterocolitica 
and the listing for Escherichia coli be 
changed to refer to “all 
enteropathogenic, enterotoxigenic, 
enteroinvasive, and strains bearing K1 
antigen;" (b) Vesicular stomatitis virus 
be listed as a Class 2 viral agent rather 
than a Class 3 viral agent; (c) Rabies 
street virus be classified as a Class 3 
viral agent for all procedures; (d) 
Alastrim, Smallpox, and Whitepox 
should be listed as Class 5 viral agents 
rather than as Class 3 and Class 4 
agents as the study of these viruses is 
restricted to a single national facility 
(WHO Collaborating Center for 
Smallpox Research, Centers for Disease 
Control) and the language dealing with 
Poxviruses modified accordingly; (e) 
Viruses classified as low risk oncogenic 
viruses by the National Cancer Institute 
Safety Standards for Research Involving, 
Oncogenic Viruses (October 1974, U.S. 
Departnment of Health. Education, and 
Welfare Publication Number (NIH) 75- 
790) should be classified as Class 2 
agents for the purposes of the 
Guidelines; and (^ Moderate-risk 
oncogenic viruses should be classified 
as Class 3 agents for Uie purposes of the 
Guidelines. Furthermore, footnotes, 
references, and the title of Appendix B 
should be modified to reflect the status 
of a revised Appendix B. 
The working group dealt with the 
issue of the composition of the 
Institutional Biosafety Committees 
(IBCs). A discussion arose as to the 
necessity of stating in ciurent Section 
IV-D-2-a that not less than 20% of the 
membership of the IBC shall not be 
affliated with the institution. It was felt 
that the 20% specification limits the 
flexibility of the university in appointing 
members to the IBC. The example was 
offered of an IBC fulfilling the 20% 
specification, but wishing to add an 
additional specialist affiliated with the 
university. However, non-affiliated 
representation would fall below 20% 
when this specialist is appointed and 
the uiiiversity would have to appoint 
another non-affiliated member. The 
specification that at least two members 
shall not be affiliated with the 
institution should remain in the 
Guidelines to ensme community 
representation. It was felt that in a 
twenty member committee, two public 
members would provide adequate 
representation for the community. 
Members of the working group could not 
envisage IBCs larger than 20 members 
functioning smoothly. In addition, it was 
noted that ORDA reviews IBC 
membership for compliance and would 
be alert to cases in which an institution 
might attempt to dilute community 
representation by, for example, 
appointing a 50 member committee. 
The working group also considered 
the language of current Section IV-D-2- 
b. A discussion ensued regarding 
representation on the IBC from the 
laboratory technical staff. If the term 
“nondoctoral” was deleted, postdoctoral 
associates might also be appointed to 
the IBC. Other members of the working 
group pointed out that technicians are, 
indeed, those most likely to be 
performing recombinant DNA 
experiments and those having the least 
“competitive” pressures exerted on 
them. Although technicians do 
experience certain types of pressures, 
many on the working group felt they 
would be among the best 
“watchpersons.” 
The working group also recommended 
a number of additional changes in the 
Guidelines. The recommendations of the 
working group, with minor modifications 
introduced by NIH staff, are 
summarized in part B of this 
announcement. The proposed revised 
Guidelines (incorporating the changes 
described in part B of this 
announcement) are given in their 
entirety in part C. Several additional 
proposed changes are given in part D. 
B. Summary of Proposed Changes 
Specifically, the proposed 
modifications would accomplish both a 
reorganization of the Guidelines, and a 
revision of the specific language of 
certain sections. The proposed 
reorganization of the Guidelines would 
require renumbering of several sections 
and minor editorial changes throughout 
the document to reflect this 
renumbering. These minor changes will 
not be enumerated below, but interested 
individuals may refer to the proposed 
revised Guidelines, which are reprinted 
in toto in part C. The major proposed 
revisions are enumerated below. 
Readers should note that sections which 
are proposed for revision are identified 
by their current Section numbering. The 
proposed modified language, however, 
is identified by new Section numbering 
when renumbering would occur in that 
section. 
1. Section I. Scope of the Guidelines. 
a. The text from Section FV-B, General 
Applicability, would be moved to 
Section I-C, General Applicability, and 
be renumbered. 
b. The text from Sections IV-C, 
General Definitions, would be moved to 
Section I-D, General Definitions, witii 
the exception of Section IV-C-1, IV-C- 
2, and rV-C-8 which would be deleted. 
Section IV-C-1 currently reads as 
follows: 
“IV-C-1. 'DNA’ means 
deoxyribonucleic, acid.” 
Section IV-C-2 currently reads as 
follows: 
“IV-C-2. ‘Recombinant DNA’ or 
‘recombinant DNA molecules’ means 
either (i) molecules which are 
constructed outside living cells by 
joining natural or synthetic DNA 
segments to DNA molecules that can 
replicate in a living cell, or (ii) DNA 
molecules which result from the 
[ 434 ] 
